guaifenesin and dextromethorphan hydrobromide

guaifenesin and dextromethorphan hydrobromide
SPL v1
SPL
SPL Set ID d0d7d651-0e5b-445a-8549-03795383d56c
Route
oral
Published
Effective Date 2025-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (10 mg) guaifenesin (100 mg)
Inactive Ingredients
citric acid fd&c red no. 40 glycerin propylene glycol water sodium benzoate sodium citrate sodium saccharin sorbitol solution cherry sucralose

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-02-01

Description

(in each 5 mL teaspoonful)                                    Purpose Dextromethorphan Hydrobromide 10 mg...........Cough Suppressant Guaifenesin 100 mg.............................................Expectorant


Medication Information

Warnings

Do not exceed recommended dosage.

Uses

temporarily Relieves

- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

- the intensity of coughing

- the impulse to cough to help you get to sleep

Directions

do not exceed recommended dosage.

adults and children 12 years and over: 2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours or as directed by a doctor
children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours or as directed by a doctor
children under 6 years of age: consult a physician

Other Information

- store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]

- tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Inactive Ingredients

cherry flavor, citric acid, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose.

Description

(in each 5 mL teaspoonful)                                    Purpose Dextromethorphan Hydrobromide 10 mg...........Cough Suppressant Guaifenesin 100 mg.............................................Expectorant

Principal Display Panel

Oncor Pharmaceuticals

NDC 83720-501-16

Guaifenesin and Dextromethorphan hydrobromide USP

100 mg/10 mg

Expectorant

Cough Suppressant

Non Drowsy - Alcohol Free

For Ages 12 & Up

CHERRY FLAVOR

NET WT. 16 fl. oz. (473 ml)

NDC 83720-501-08

Guaifenesin and Dextromethorphan hydrobromide USP

100 mg/10 mg

Expectorant

Cough Suppressant

Non Drowsy - Alcohol Free

For Ages 12 & Up

CHERRY FLAVOR

NET WT. 8 OZ. (237 ml)

Manufactured In USA For :

Oncor Pharmaceuticals

6755 Business Pkwy Suite 202

Elkridge, MD 21075

United States.

Rev. 02/25

Questions?

You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.

Section 34088-5

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Section 50565-1

Keep out of reach of children.

Section 51945-4

Active Ingredients

(in each 5 mL teaspoonful)                                    Purpose

Dextromethorphan Hydrobromide 10 mg...........Cough Suppressant

Guaifenesin 100 mg.............................................Expectorant

Do Not Use This Product

If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Stop Use and Ask A Doctor If

- cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Ask A Doctor Before Use If You Have

- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

- cough that occurs with too much phlegm (mucus)


Structured Label Content

Warnings

Do not exceed recommended dosage.

Uses

temporarily Relieves

- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

- the intensity of coughing

- the impulse to cough to help you get to sleep

Directions

do not exceed recommended dosage.

adults and children 12 years and over: 2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours or as directed by a doctor
children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours or as directed by a doctor
children under 6 years of age: consult a physician

Other Information (Other information)

- store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]

- tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Inactive Ingredients (Inactive ingredients)

cherry flavor, citric acid, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose.

Principal Display Panel

Oncor Pharmaceuticals

NDC 83720-501-16

Guaifenesin and Dextromethorphan hydrobromide USP

100 mg/10 mg

Expectorant

Cough Suppressant

Non Drowsy - Alcohol Free

For Ages 12 & Up

CHERRY FLAVOR

NET WT. 16 fl. oz. (473 ml)

NDC 83720-501-08

Guaifenesin and Dextromethorphan hydrobromide USP

100 mg/10 mg

Expectorant

Cough Suppressant

Non Drowsy - Alcohol Free

For Ages 12 & Up

CHERRY FLAVOR

NET WT. 8 OZ. (237 ml)

Manufactured In USA For :

Oncor Pharmaceuticals

6755 Business Pkwy Suite 202

Elkridge, MD 21075

United States.

Rev. 02/25

Questions?

You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.

Section 34088-5 (34088-5)

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Active Ingredients (Active ingredients)

(in each 5 mL teaspoonful)                                    Purpose

Dextromethorphan Hydrobromide 10 mg...........Cough Suppressant

Guaifenesin 100 mg.............................................Expectorant

Do Not Use This Product (Do not use this product)

If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

- cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

- cough that occurs with too much phlegm (mucus)


Advanced Ingredient Data


Raw Label Data

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